Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy

Ectopic Pregnancy Clinical Trial

— ABPEP  

Official title:

Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04738370
• Other study ID #: 14HH2202
• Status: Recruiting
• Start date: December 8, 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: Imperial College London
• Contact: Tom Bourne, MBBS, PhD, MRCOG
• Phone: 0044 203 313 5131
• Email: t.bourne[@]ic.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To further develop the patient care pathway for women classified with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP).

Description:

Purpose and design-There is a need for the patient care pathway to evolve in order to aid and improve the diagnosis and management of women with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP). There is potential for this to be achieved by the incorporation of a statistical model that uses one or more novel markers identified by this study.

Recruitment-1000 patients. Inclusion: Patients attending the Early Pregnancy Unit (EPU) in the first trimester with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan between the ages of 18-50 years. Exclusion: Patients diagnosed with cancer, presence of acute medical condition, patients aged less than 18 years, patients who cannot give fully informed study consent.

Consent - Posters will advertise the study. Patients in EPU will be invited to the study by a member of the clinical care team. Written consent will be required.

Confidentiality - The Chief Investigator will preserve the confidentiality of participants taking part in the study and is registered under the Data Protection Act. Patient consent forms will be stored securely within the study file. All patient identifiable information, where required, will be stored electronically on National Health Service (NHS) approved computers, accessible only by personnel involved in the study via password.

Conflict of interest - None involved in the study have a conflict of interest. Dissemination of results - No patient identifiable information will be included in the research report or publication. Anonymised results will be disseminated to scientific community by means of publication in peer-reviewed literature and presented at national and international meetings.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients attending the Early Pregnancy Unit in the first trimester of pregnancy (=14 weeks gestation) aged between 18-50 years old and categorized as having a PUL or ectopic pregnancy

Exclusion Criteria:

• Younger than 18 years of age

• Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study

• Viable intrauterine pregnancy (the presence of a fetal pole with a fetal heartbeat within the uterine cavity)

• Miscarriage

• Presence of an acute medical condition

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Early Pregnancy
• Early Pregnancy Loss
• Ectopic Pregnancy
• Pregnancy of Unknown Location
• Pregnancy, Ectopic

Intervention

Other:
• Sample collection
Bloods +/- urine +/- vaginal swabs taken

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PUL outcome prediction	The number of PUL patients correctly categorised as 'low risk' or 'high risk' based on the new logistical regression model	7 years
Secondary	Urinary BhCG and PUL	The number of PUL patients correctly categorised as 'low risk' or 'high risk' based on the interpretation of urine (rather than serum) BhCG	7 years
Secondary	Urine BhCG and Ectopic pregnancy	The number of ectopic pregnancies correctly risk stratified as being suitable for expectant or medical management based on the interpretation of urine (rather than serum) BhCG	7 years
Secondary	Plasma and Serum and PUL	Whether novel biomarkers present in serum and/or plasma and/or urine may have predictive value in determining 'low risk' versus 'high risk' PUL	7 years
Secondary	Plasma and Serum and Ectopic pregnancy	Whether novel biomarkers present in serum and/or plasma and/or urine may have predictive value in determining which women diagnosed with an ectopic pregnancy are suitable for expectant or medical management	7 years
Secondary	BhCG timing	Whether the timing of serial BhCG measurements has a significant impact on the risk stratification of PUL patients	7 years
Secondary	Novel biomarkers	Whether a novel candidate metabolite may have predictive value in determining 'low risk' versus 'high risk' PUL	7 years
Secondary	Other novel biomarkers	Whether a novel candidate metabolite may have predictive value in determining which women diagnosed with an ectopic pregnancy are suitable for expectant or medical management	7 years